FDA Panel Green Lights Edwards Heart Valve

Edwards Sapien transcatheter heart valve approved by FDA panel

(RxWiki News) After a full day of debate a U.S. Food and Drug Administration panel approved the Edwards Lifesceinces' Sapien transcatheter heart valve system in a 9-0 vote. One member abstained from voting.

The device could aid patients with severe aortic stenosis who are unable to withstand open-heart surgery. That generally includes the elderly and those considered too sick or weak to withstand such an invasive operation.

"Ask your doctor about the most suitable valve treatment for your situation."

The Edwards device will mark the first transcatheter aortic valve to be used in the United States, though the valve has been available in Europe for the last four years. The FDA will make a final decision at a later debate, but it is expected that it will follow the panel's recommendation.

The less-invasive device is threaded into place through a major artery in the leg, then up to the heart. The device then opens, creating an artificial replacement for the body's natural heart valve.

In patients with aortic stenosis the heart must work harder to pump blood, which could lead to heart failure, blood clots and sudden cardiac death.

Separately, the panel voted only 7-3 that the valve would be safe. However, for patients with no other options the treatment is likely their best bet. There are concerns about increased risk of stroke and heart complications with use of the implanted valve.

Edwards may at some point seek approval of the valve option for patients who are not too sick for open-heart surgery, but would prefer the less invasive option. It was only approved for patients who are too frail or ill for the traditional treatment.

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Review Date: 
July 20, 2011